QUANTIFICATION OF 19 CANNABINOIDS IN COMMERCIAL CBD OILS AND SAFETY IMPLICATIONS OF THEIR CBD AND Δ9-THC CONTENTS

CBD oils are a group of products typically consisting of hemp extracts containing cannabinoids such as cannabidiol (CBD) or tetrahydrocannabinol (Δ 9-THC). These extracts are mixed with edible oils such as hemp seed, sesame or olive oil. Common consumer expectations when using CBD oils are pain and stress relief, relaxation, or improved sleep. CBD oils are often marketed as food/food supplements or cosmetics, although consumer surveys clearly indicate the use as self-medication. While the substance CBD is approved as a prescription medicine (anticonvulsant Epidyolex®) in the EU and US, CBD oils are not, and there is no clear clinical evidence for the effects consumers expect. The European Food Safety Authority (EFSA) has suspended the evaluation of pending applications for CBD under the Novel Foods Regulation due to data gaps and uncertainties regarding potential adverse health effects. CBD oils marketed as food or food supplements violate EU food law as they are considered unauthorised novel foods. Δ 9-THC is regulated with maximum levels in hemp seeds and processed hemp seed products, but CBD oils are not regulated in this respect. Δ 9-THC is relevant, because of its psychoactive effects. In its toxicological evaluation, EFSA has derived an acute reference dose (ARfD) of 1 μg/kg body weight (bw). An HPLC-MS/MS method was used to quantify 19 cannabinoids in 22 CBD, 2 cannabigerol (CBG) and 2 cannabinol (CBN) oils (n = 26). The CBD content of the samples ranged from 3.1 to 24.2%. While EFSA has not yet derived a health-based guidance value, the UK Advisory Committee on Novel Foods and Processes (ACNFP) has established a provisional acceptable daily intake (ADI) of 0.15 mg/kg bw. For 24 samples, 2-7 drops would be sufficient to exceed this provisional ADI for a 70 kg person. At higher consumption levels of 20 to 100 drops or more per day, therapeutic doses recommended for Epidyolex® (350 mg/d for a 70 kg person) could be reached. Δ 9-THC levels ranged from 5 to 1,576 mg/kg. For 13 samples, 1-20 drops would be sufficient to exceed the ARfD for a 70 kg person. For 7 of these 13 samples, only 2 drops would suffice. The compound (R)-HHC, which can cause effects similar to Δ 9 -THC, though likely higher doses are necessary, was quantified in 2 CBN oils at levels of 5 and 110 mg/kg.